160)
No. Deaths / n (%) 65/80 (81%) 64/80 (80%)
Median OS Duration (mos.) 10.8 12.3
95% CI (mos.) (6.8, 12.8) (9.5, 15.7)
Hazard ratio (95% CI) 0.78 (0.55, 1.10)
FISH+ or FISH- / IHC3+c subgroup (N=294)
No. Deaths / n (%) 104/143 (73%) 96/151 (64%)
Median OS Duration (mos.) 13.2 18.0
95% CI (mos.) (11.5, 15.2) (15.5, 21.2)
Hazard ratio (95% CI) 0.66 (0.50, 0.87) a Two patients on the FC arm who were FISH+ but IHC status unknown were excluded from theexploratory subgroup analyses.
b Five patients on the trastuzumab-containing arm who were FISH+, but IHC status unknown were excludedfrom the exploratory subgroup analyses.
c Includes 6 patients on chemotherapy arm, 10 patients on trastuzumab arm with FISH-, IHC3+ and 8 patientson chemotherapy arm, 8 patients on trastuzumab arm with FISH status unknown, IHC 3+.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TRAZIMERA (trastuzumab-qyyp) for injection 420 mg/vial is supplied in a multiple-dose vial as a sterile,white lyophilized powder. Each carton contains one multiple-dose vial of TRAZIMERA and one vial (20 mL)
of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol as a preservative.
NDC 0069-0305-01.
16.2 Storage
Store TRAZIMERA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from
light.
If needed, unopened TRAZIMERA vials may be removed from the refrigerator and stored at room temperatureup to 30°C (86°F) for a single period of up to 3 months in the original carton to protect from light. Onceremoved from the refrigerator, do not return to the refrigerator and discard after 3 months or by the expiration
date stamped on the vial, whichever occurs first. Write the revised expiration date in the space provided on thecarton labeling.
17 PATIENT COUNSELING INFORMATION
Cardiomyopathy
• Advise patients to contact a health care professional immediately for any of the following: new onset orworsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weightgain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning].
Embryo-Fetal Toxicity
• Advise pregnant women and females of reproductive potential that TRAZIMERA exposure duringpregnancy or within 7 months prior to conception can result in fetal harm. Advise female patients to contacttheir healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)].
• Advise females of reproductive potential to use effective contraception during treatment and for 7 monthsfollowing the last dose of TRAZIMERA [see Use in Specific Populations (8.3)].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf
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